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FDA approves Ipsen’s Bylvay for cholestatic pruritus due to ALGS

Pharmaceutical Technology

Ipsen has received US Food and Drug Administration (FDA) approval for Bylvay (odevixibat) to treat patients aged 12 months and above with cholestatic pruritus caused by Alagille syndrome (ALGS).

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Delivery systems for biologics

European Pharmaceutical Review

Indeed, in 2022, biologics constituted 40 percent of all US Food and Drug Administration (FDA) approved drugs, projecting a compound annual growth rate (CAGR) of 9.5 A possible solution could be tailoring biologics delivery systems to facilitate in vivo transport for on-target delivery of the safeguarded payload. percent through 2027.

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The FDA now recommends that clinical trial sponsors submit a Race and Ethnicity Diversity Plan

Clarify Health

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations. FDA Commissioner Robert M.

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The FDA now recommends that clinical trial sponsors submit a Race and Ethnicity Diversity Plan

Clarify Health

The US Food and Drug Administration (FDA) recently announced new draft guidance for life science companies on increasing diversity and inclusion in clinical trials to improve enrollments of underrepresented racial and ethnic populations. FDA Commissioner Robert M.

FDA 52
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The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

Members of a multidisciplinary care team may include physicians, nurses, pharmacists, radiologists, dieticians…the list goes on. 80% provide transportation 1. The FDA has studied the importance of caregivers to drug development and regulatory decision-making. But one key member is often omitted: the patient’s caregiver.

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T2D market growth driven by novel GLP-1RAs and once-weekly basal insulin therapies

Pharmaceutical Technology

The erosion of Januvia is due to patent expiry in that had been expected in 2022 and physicians’ preference for sodium-glucose linked transporter-2 inhibitor (SGLT-2I) therapies such as Farxiga (dapagliflozin) and Jardiance (empagliflozin) due to their ability to improve glycemic control and address cardiorenal comorbidities.

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How one pharma “family business” places patients first

pharmaphorum

There are many challenges in the development of therapies for rare diseases due to several unique factors, including small target patient populations, lack of long-term safety and efficacy data or natural history data, and often complex administration, dosing, and patient monitoring requirements,” Chiesi says.